Internet pharmacies: cyberspace versus the regulatory state.

• Author: Clevenger, Ty

At a July 30, 1999 Congressional hearing, an investigative journalist testified that he was able to order Viagra for his cat, Tom, using the cat's actual height and weight. (2) In other instances, the reporter and a colleague were able to obtain Viagra for a ninety-eight year old man and a prescription diet drag for a seven-year-old girl. (3) In testimony before the same Congressional subcommittee, Dr. Janet Woodcock, the director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration [hereinafter "FDA"] said FDA investigators have found websites offering kits for making homemade drugs, home abortion kits, and unapproved HIV home test kits. (4) Woodcock complained of doctors who work with (or for) online pharmacies, sending prescriptions across the Internet on the basis of an electronic questionnaire. (5) Woodcock said some of the physicians prescribe to anyone sight unseen--perhaps like "Tom"--without even requiring a questionnaire. (6)

As Woodcock and her colleagues have learned, Internet pharmacies are a nightmare for regulators. The unique qualities of e-commerce make it difficult to regulate under any circumstances, but the growth of online pharmacies in particular is far outpacing the ability of government officials to investigate and enforce existing drug laws. In 1999, Americans spent an estimated $44 million purchasing prescription drugs from online pharmacies, a figure that is projected to reach $1 billion per year by 2003. (7) In December of 1999, President Clinton proposed $10 million in new funding for the FDA to regulate Internet pharmacies and hire 100 new employees, (8) but the FDA has yet to explain whether this would be enough to keep up with the rapid growth of online pharmacies. Clinton also proposed raising civil fines as high as $500,000 for pharmacies and pharmacists who violate state and federal drug laws, and he proposed giving the FDA administrative subpoena authority. (9) Several members of Congress have proposed their own legislation, (10) and last year Democrats on the House Commerce Committee asked the General Accounting Office to investigate online pharmacies. (11) This paper will consider the current laws governing online pharmacies (to the limited extent the state of the law can be discerned), the practical limits of traditional regulation and enforcement, and possible legal and regulatory responses to online pharmacies.

2. THE NEW TELEMEDICINE

   "Telepharmacy" could have an enormous impact on the legal and regulatory boundaries of the overall field of telemedicine and perhaps electronic commerce in general. Online pharmacies are a collision in progress between the free-wheeling atmosphere of the Internet and one of the most tightly regulated industries in the United States. On December 28, 1999, when President Clinton proposed the new enforcement powers for the FDA, it marked the first major attempt by the federal or state governments to regulate electronic commerce other than child pornography. (12) Even at this early stage, online pharmacies are capable of raising Constitutional questions of state police powers versus federal regulation of interstate commerce. State and federal officials will be forced to reconsider what constitutes the practice of medicine and who should regulate it. Legal and ethical questions for physicians--not just pharmacists--appear to be arising much more quickly in the context of telepharmacy than the traditional realm of telemedicine. (13)

   Yet to some extent, the recent regulatory hoopla about Internet pharmacies can be misleading. To be sure, online pharmacies raise plenty 6f novel legal questions, but many of the legal issues pertinent to online pharmacies have already been raised in analogous areas of practice, such as mail-order pharmacy and telemedicine. What appears to have changed is the volume of activity and the practicality of enforcement: the amount of prescription drugs intercepted by the U.S. Customs Service is a good indicator of the growth in sales. "We've been deluged with prescription drags coming in from overseas," said U.S. Customs Service Commissioner Raymond Kelly in an interview with the New York Times. (14) "It's a major challenge to deal with this huge increase in volume." (15) In 1999, the Customs Service seized 9725 packages with prescription drugs, up from 2145 packages the year before. (16) The number of pills and tablets impounded jumped from 760,720 in 1998 to 1.9 million in 1999. (17) And federal officials say the impounded drugs probably represent only a small fraction of what consumers import illegally. (18)

   Though regulators and academics have been trying to anticipate the impact of telemedicine for twenty years or more, the phenomenon of online pharmacies seems to have caught them off guard. That is probably because commentators focused almost exclusively on "traditional" telemedicine, namely the role of practitioners who use telecommunications to consult with other practitioners or with patients. Issues of interstate health care delivery are not new, but the case law is not particularly well developed for the very reason that cases involving interstate medicine did not arise that often. Many of the appellate cases, for example, dealt with choosing the correct state forum for a medical malpractice case. (19) Regulatory concerns seem to have been an afterthought. Even now, regulators and legislators are focusing far less attention on traditional telemedicine because it doesn't seem to have been the source of any major public health problems. By contrast, regulators fear online pharmacies in the United States and overseas pose a substantial threat to public health. (20)

   In 1998, after police in Illinois found a man lying unconscious in a hotel parking lot, FDA officials learned he had purchased a kit to make GHB (an illegal steroid frequently used by bodybuilders) and overdosed on his homemade drugs. (21) A fifty-two year-old Illinois man with episodes of chest pain and a family history of heart disease died of a heart attack in March 1999 after buying Viagra from an online source, even though Viagra is not recommended for anyone with heart disease. (22) FDA officials say there is no proof linking the man's death to the drug, but add the problems likely would have been discovered within the traditional doctor-patient relationship. (23) In any event, FDA official Woodcock said the sheer volume of electronic drug sales forces FDA officials to rely on "triage" in deciding which cases to investigate. (24)

   States have also joined the fight against unregulated pharmacies. The attorneys general of Kansas, Illinois, and Missouri sued out-of-state pharmacies and doctors who were operating online, and the courts in Kansas and Missouri have issued injunctions. (25) Kansas Attorney General Carla J. Stovall sued seven companies, six doctors, four other individuals, and three out-of-state pharmacies after a state investigation uncovered online vendors willing to sell prescription drugs directly to minors. (26) A minor, acting under the direction of one of the agents, was able to purchase Viagra and the diet-drug Meridia using his true age and his mother's credit card. (27) The companies did not require parental consent and required no examination or consultation with a physician. (28)

   Meanwhile, libertarians and even state governments have warned that the FDA may be trying to extend its regulatory reach too far. One group, the "Life Extension Foundation," assailed the FDA for citing the Illinois man who died of a heart attack:

   The FDA is using this one death as an example of why the FDA needs to impose dictatorial power over all health websites. One problem with this position is that, as of November 1998, at least 130 Americans died from taking Viagra legally prescribed by their doctors.... The FDA failed to detect the lethal side effects of Viagra, yet it is now seeking gestapo-like power to attack any Internet health company it wishes to, without due process. (29) Representatives of state pharmacy boards have been considerably less strident in their criticism, but are nonetheless wary of a larger FDA role. (30) The National Assocation of Boards of Pharmacy, which represents the boards of pharmacy of all U.S. states and territories, and the District of Columbia, has created its own voluntary certification program and does not want the FDA trying to duplicate state functions. (31)

3. WHERE IS CYBERSPACE AND WHAT HAPPENED THERE?

   The allegations in the Kansas suit illustrate some of the jurisdictional questions facing not only pharmacy regulators, but Interact regulators generally. For example, Attorney General Stovall claimed the defendants sold, and prescribed Viagra "in the state of Kansas." (32) But the defendant corporation was actually located in Nevada--so where did the actual sale take place? (33) In Kansas, in Nevada, or in the nebulous realm of cyberspace? Defining "prescribed" and "dispensed" are even more problematic for Stovall. One could argue that the doctor does the prescribing--the patient only receives the prescription--and the doctor was not in Kansas. Moreover, Stovall accused the defendant doctors of practicing medicine in Kansas without a license from Kansas medical authorities. (34) But if the doctor had legal authority to prescribe in Nevada (leaving aside the issue of whether Nevada allows doctors to prescribe without an examination) and the prescription was filled in Nevada, then the question of whether he practiced medicine in Kansas becomes even more complex.

   Prior cases in interstate medicine do not really address these issues directly, but instead the state courts analyzed whether sufficient minimum contacts occurred between the patient and an out-of-state physician to justify in personam jurisdiction over the out-of-state physician. Perhaps the most widely cited of these cases is Wright v. Yackley. (35) While living in South Dakota, the plaintiff was...